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Bladder CancerPhase 2BOND2NCT02365818

Safety and Efficacy of CG0070 Oncolytic Virus Regimen for High Grade NMIBC After BCG Failure

A Phase 2 study testing CG0070 in people with Bladder Cancer, run by CG Oncology, Inc. at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To study the safety and efficacy of CG0070, an oncolytic virus expression GM-CSF in high grade non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
CG0070
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
17 sitesUnited States
Study dates
2 Jun 2015to Feb 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have pathologically confirmed non-muscle invasive bladder cancer (NMIBC) high grade disease (HG), as defined by the 2004 WHO classification system
  • Patients must have no evidence of muscle invasive disease
  • Patients must be able to provide a sufficient biopsy sample to the central pathologist for histopathologically confirmed, transitional cell (urothelial) carcinoma. Urothelial tumors with mixed histology (but with <50% variant) are eligible.
  • Patients must have received at least two or more prior courses of intravesical therapy per recommended schedules. Bacillus Calmette-Guerin (BCG) must have been one of the prior therapies administered.
  • Patients can have either failed BCG induction therapy within a six-month period or have been successfully treated with BCG, but subsequently found to have recurrence. The first standard course of intravesical BCG therapy must include at least six weekly treatments (allowable range of instillations per course is 4-9). The second course of BCG therapy must include at least two weekly treatments.
  • Patients have either Cis or Cis with Ta and/or T1 disease at enrollment or in the past. For those patients with only Ta or T1 disease at enrollment AND with no history of Cis, they must have
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  • disease recurrence either must occur within 12 months of the most recent intravesical therapy of any kind, OR
  • disease recurrence within 18 months of BCG maintenance OR
  • disease recurrence within 24 months of BCG induction
  • T1 patients need to have evidence of muscle included in their latest biopsy; and if not a re-TURBT has to be done prior to enrollment
  • 18 years of age or older
  • Radical cystectomy has been declined by the patient in a signed special section of the informed consent, whereby there is a clear explanation by the investigator to the subject that a delay of cystectomy may increase his/her chance of disease progression, the results of which may lead to serious and life threatening consequences.
  • Patients must be able to enter into the study within ten weeks of their most recent diagnostic procedure, which is usually a diagnostic biopsy, a transurethral resection of bladder tumor (TURBT) procedure or positive urine cytology.
  • Eastern Cooperative Oncology Group (ECOG) performance status <2.
  • Not pregnant or lactating
  • Patients with child bearing potential must agree to use adequate contraception
  • Agree to study specific informed consent and HIPAA authorization for release of personal health information
  • Adequate baseline CBC, renal and hepatic function. Parameters described as WBC>3000 cells/mm^3, ANC>1,000 cells/mm^3, hemoglobin>9.5g/dL, and platelet count >100,000 cells/mm^3
  • Adequate renal function: serum creatinine <2.5mg/dL
  • Bilirubin, AST and ALT not more than 2 x Upper Limits of Normal
  • PT/INR, PTT, and fibrinogen within institutional acceptable limits
  • Absolute lymphocyte count ≥ 800/μL before the first dose of CG0070

Who cannot join

  • Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior immunotherapy or intravesical (administered within the bladder) chemotherapy for superficial disease is acceptable
  • History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products, clinically meaningful allergic reactions or any known hypersensitivity or prior reaction to any of the formulation excipients in the study drugs.
  • Known infection with HIV, HBV or HCV.
  • Anticipated use of chemotherapy or radiotherapy not specified in the study protocol while on study
  • Any underlying medical condition that, in the Investigator's opinion, will make the administration of study vector hazardous to the patient, would obscure the interpretation of adverse events, or not permit adequate surgical resection.
  • Systemic treatment on any investigational clinical trial within 28 days prior to registration.
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  • Concurrent treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (exception: inhaled or topically applied steroids, and acute and chronic standard dose NSAIDs, are permitted). Use of a short course (i.e., ≤ 1 day) of a glucocorticoid is acceptable to prevent a reaction to the IV contrast used for CT scans.
  • Immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry.
  • History of prior experimental cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine) within the last year
  • History of stage III or greater cancer, excluding urothelial cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer, must have been adequately treated and have been disease-free for ≥ 2 years at the time of registration.
  • Progressive or persistent viral or bacterial infection
  • All infections must be resolved and the patient must remain afebrile for seven days without antibiotics prior to being placed on study
  • Urinary tract infection, including particularly bladder infection, must be resolved prior to being placed on study
  • Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Alaska Clinical Research Center

    Anchorage, Alaska, 99503

  • University of Chicago

    Chicago, Illinois, 60637

  • The Urology Group

    Cincinnati, Ohio, 45212

  • Premier Urology Group, LLC.

    Edison, New Jersey, 08837

  • UF Health Cancer Center

    Gainesville, Florida, 32610

  • Institute of Urologic Oncology at UCLA

    Los Angeles, California, 90095

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Vanderbilt University Medical Center, Dept. of Urologic Surgery

    Nashville, Tennessee, 37232

  • Adult Pediatric Urology and Urogynecology, PC

    Omaha, Nebraska, 68114

  • GU Research Network/ The Urology Center

    Omaha, Nebraska, 68130

  • UC Irvine Medical Center

    Orange, California, 92868

  • BCG Oncology

    Phoenix, Arizona, 85032

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12061

  • University of California, San Diego

    San Diego, California, 92093

  • Michigan Institute of Urology, P.C.

    Troy, Michigan, 48084

  • Arizona Institute of Urology

    Tucson, Arizona, 85704

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: An Open Label, Single Arm, Phase II, Multicenter Study of the Safety and Efficacy of CG0070 Oncolytic Vector Regimen in Patients With Non-Muscle Invasive Bladder Carcinoma Who Have Failed BCG (Bacillus Calmette-Guerin) Therapy and Refused Cystectomy

To study the safety and efficacy of CG0070, an oncolytic virus expression GM-CSF in high grade non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy.

Read the detailed description

The plan is to study the safety and efficacy of CG0070 in high-grade NMIBC (Non-muscle Invasive Bladder Cancer) patients who failed BCG therapy. Most patients with NMIBCis (Cis, Cis with Ta and/or T1, high grade Ta or T1 with frequent or uncontrolled recurrences) who have failed BCG (Bacillus Calmette-Guerin) intravesical therapy (standard of care) usually have no other choice but to proceed to cystectomy. Cystectomy is a surgery associated with major morbidity, mortality and quality of life issues. Morbidity and long term tedious medical care will be for the rest of the patient's life span. Most patients at this stage do not show signs of disease progression into the muscle layer or of metastasis, making surgery a very difficult decision. CG0070, if successful in this trial, will serve to provide a therapeutic alternative for this patient population in need.

Conditions
Bladder Cancer
Being tested
CG0070
Keywords
Bladder Cancer
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CG0070Biological

    Also called oncolytic adenovirus with a E2F promotor and expresses GMCSF

Study groups in NCT02365818
Study groupRoleWhat they receive
CG0070ExperimentalSingle arm intervention with CG0070 to be given at a dose of 1e12 vp weekly for six weeks. Patients who achieve a partial response or a complete response at 6 months post first intravesical intervention will be maintained with the same induction cycle of weekly times six. Patients will be followed every 3 months through Month 24.
Receives: Biological: CG0070

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Durable Complete Response Proportion (DCR)

    Defined as the proportion of patients who experience a durable complete response lasting 12 months or longer from the initial confirmed complete response date (first CR assessment to be at least 6 months after the first intravesical intervention) and at least 18 months from the date of the first intravesical intervention

    Measured: 18 months time point from the date of the first intravesical intervention

Secondary outcomes (10)

  1. Cystectomy Free Survival

    Not available, not collected on study or not currently available

    Measured: 18 months after the first intravesical treatment

  2. Complete Response Survival

    Not available, not collected on study or not currently available

    Measured: 18 months after the first intravesical treatment

  3. Progression Free Survival

    Not available, not collected on study or not currently available

    Measured: 18 months after the first intravesical treatment

  4. Time to Progression to Muscle Invasive Disease

    Not available, not collected on study or not currently available

    Measured: 18 months after the first intravesical treatment

  5. Overall Survival

    Not available, not collected on study or not currently available

    Measured: 18 months and 24 months after first intravesical treatment

  6. PD-L1 Status Changes

    PD-L1 status of cancer cells and immune cells at tumor site by IHC

    Measured: changes between pre-intervention and post intervention at either cystectomy or at biopsy up to 24 months

  7. Organ Confined Disease Proportions

    Patient proportions with no cancer cells in regional lymph nodes at cystectomy

    Measured: at cystectomy

  8. Complete Response Proportions

    Proportions of patients with a complete response of at least 12 months' duration

    Measured: 24 months after the first intravesical treatment

  9. PD-1 Status Changes

    PD-1 status of immune cells at tumor site by IHC

    Measured: changes between pre-intervention and post intervention at either cystectomy or at biopsy up to 24 months

  10. Disease Regression Proportions

    Proportions of patients with a partial response and/or a complete response of less than 12 months' duration

    Measured: 24 months after the first intravesical treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2015 (estimated)
  2. Study start2 Jun 2015
  3. Primary completionAug 2018
  4. Study completionFeb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02365818
Sponsor's protocol ID
BOND 2 version 3.8
Acronym
BOND2
Status last verified
Apr 2021
First submitted
9 Feb 2015
Last updated
14 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CG0070 in people with Bladder Cancer, run by CG Oncology, Inc. at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Durable Complete Response Proportion (DCR) (time frame: 18 months time point from the date of the first intravesical intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02365818.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.

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